Active, not recruitingNCT04770753Updated Sep 28, 2026Results posted

A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)

A Phase 3 interventional study of Placebo Matching Mitapivat and Mitapivat in Non-Transfusion-dependent Alpha-Thalassemia and Non-Transfusion-dependent Beta-Thalassemia, sponsored by Agios Pharmaceuticals, Inc.. Active, not recruiting at 68 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Agios Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 194
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The primary purpose of this study was to compare the effect of mitapivat versus placebo on hemolytic anemia in participants with alpha- or beta-non-transfusion dependent thalassemia (NTDT).

Read the detailed description

The mitapivat group included 130 participants whereas the placebo group had 64 participants.

Conditions studied

Non-Transfusion-dependent Alpha-Thalassemia
Non-Transfusion-dependent Beta-Thalassemia

In context

Lead sponsor

Agios Pharmaceuticals, Inc. is the lead sponsor of 52 studies on the registry; 6 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 4 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Documented diagnosis of thalassemia (β-thalassemia with or without α-globin gene mutations, hemoglobin E (HbE)/β-thalassemia, or α-thalassemia/hemoglobin H [HbH] disease) based on Hb electrophoresis, Hb high-performance liquid chromatography (HPLC)), and/or deoxyribonucleic acid (DNA) analysis;
Hb concentration ≤10.0 grams per deciliter (g/dL) (100.0 grams per liter [g/L]), based on an average of at least 2 Hb concentration measurements (separated by ≥7 days) collected during the Screening Period;
Non-transfusion-dependent, defined as ≤5 red blood cell (RBC) units during the 24-week period before randomization; and no RBC transfusions ≤8 weeks before providing informed consent and no RBC transfusions during the Screening Period;
If taking hydroxyurea, the hydroxyurea dose must be stable for ≥16 weeks before randomization;
Women of child-bearing potential (WOCBP) must be abstinent of sexual activities that may result in pregnancy as part of their usual lifestyle or agree to use 2 forms of contraception, one of which must be considered highly effective, from the time of providing informed consent, throughout the study, and for 28 days after the last dose of study drug. The second form of contraception can be an acceptable barrier method;
Written informed consent before any study-related procedures are conducted and willing to comply with all study procedures for the duration of the study.

Exclusion criteria

Exclusion Criteria:

Pregnant, breastfeeding, or parturient
Documented history of homozygous or heterozygous sickle hemoglobin (HbS) or hemoglobin C (HbC);
Prior exposure to gene therapy or prior bone marrow or stem cell transplantation;
Currently receiving treatment with luspatercept; the last dose must have been administered ≥18 weeks before randomization;
Currently receiving treatment with hematopoietic stimulating agents; the last dose must have been administered ≥18 weeks before randomization;
History of malignancy, (active or treated) ≤5 years before providing informed consent;
History of active and/or uncontrolled cardiac or pulmonary disease ≤6 months before providing informed consent, except for nonmelanomatous skin cancer in situ, cervical carcinoma in situ, or breast carcinoma in situ;
Hepatobiliary disorders;
Estimated glomerular filtration rate \<45 milliliters per minute (mL/min)/1.73 m\^2 by Chronic Kidney Disease Epidemiology Collaboration creatinine equation;
Nonfasting triglycerides >440 milligrams per deciliter (mg/dL) (5 millimoles per liter [mmol/L]);
Active infection requiring systemic antimicrobial therapy at the time of providing informed consent;
Positive test for hepatitis C virus antibody (HCVAb) with evidence of active HCV infection, or positive test for hepatitis B surface antigen (HBsAg);
Positive test for human immunodeficiency virus (HIV)-1 antibody (Ab) or HIV-2 Ab;
History of major surgery (including splenectomy) ≤16 weeks before providing informed consent and/or a major surgical procedure planned during the study;
Current enrollment or past participation (≤12 weeks before administration of the first dose of study drug or a timeframe equivalent to 5 half-lives of the investigational study drug, whichever is longer) in any other clinical study involving an investigational treatment or device;
Receiving strong CYP3A4/5 inhibitors that have not been stopped for ≥5 days or a timeframe equivalent to 5 half-lives (whichever is longer); or strong CYP3A4 inducers that have not been stopped for ≥4 weeks or a timeframe equivalent to 5 half-lives (whichever is longer), before randomization;
Receiving anabolic steroids that have not been stopped for at least 4 weeks before randomization. Testosterone replacement therapy to treat hypogonadism is allowed. The testosterone dose and preparation must be stable for ≥10 weeks before randomization;
Known allergy to mitapivat or its excipients (microcrystalline cellulose, croscarmellose sodium, sodium stearyl fumarate, mannitol, and magnesium stearate, Opadry® II Blue [hypromellose, titanium dioxide, lactose monohydrate, triacetin, and FD\&C Blue #2]);
Any medical, hematological, psychological, or behavioral condition(s) or prior or current therapy that, in the opinion of the Investigator, may confer an unacceptable risk to participating in the study and/or could confound the interpretation of the study data Also excluded are:
- Participants who are institutionalized by regulatory or court order
- Participants with any condition(s) that could create undue influence (including but not limited to incarceration, involuntary psychiatric confinement, and financial or familial affiliation with the Investigator or Sponsor)

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 194 participants (actual)

Study arms

Experimental
Mitapivat
Mitapivat 100 milligrams (mg), orally, twice daily (BID) for 24 weeks in double blind (DB) period and for up to 5 years in open label extension (OLE) period.
Drug: Mitapivat
Placebo comparator
Placebo
Placebo matching mitapivat, orally, BID for 24 weeks in double blind period followed by Mitapivat 100 mg, orally, BID for up to 5 years in open label extension period.
Drug: Placebo Matching Mitapivat · Drug: Mitapivat

Interventions

DrugPlacebo Matching Mitapivat
Tablets
DrugMitapivat
Tablets
Also known as: AG-348, AG-348 sulfate hydrate, Mitapivat sulfate

What researchers measure

Primary outcomes

Double-Blind Period: Percentage of Participants Who Achieved Hemoglobin (Hb) Response From Week 12 Through Week 24 Compared With Baseline
Hb response is defined as ≥10 grams/ liter (g/L) (1.0 gram per deciliter) (g/dL) increase in average Hb concentration from Week 12 through Week 24 compared with baseline. Hb response was tested using the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors. Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed.
Time frame: Double-Blind Period: Baseline up to Week 12 through Week 24

Secondary outcomes

Double-Blind Period: Change From Baseline in Average Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue Subscale Score From Week 12 Through Week 24
The FACIT-Fatigue subscale includes a 13-item self-reported fatigue subscale, which assesses the severity and impact of fatigue (including the impact on daily activities and functioning).The FACIT-Fatigue subscale is scored on a 5-point Likert scale: 0 (not at all) to 4 (very much). The total FACIT-Fatigue subscale score ranges from 0 to 52, with a higher score indicating better health-related quality of life (HRQOL). Baseline is defined as the last assessment before randomization for subjects randomized and not dosed or the last assessment before start of study treatment for subjects randomized and dosed.
Time frame: Double-Blind Period: Baseline, Week 12 through Week 24
Double-Blind Period: Change From Baseline in Average Hb Concentration From Week 12 Through Week 24
Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed.
Time frame: Double-Blind Period: Baseline, Week 12 through Week 24
Double-Blind Period: Percentage of Participants Who Achieved Hb 1.5+ Response From Week 12 Through Week 24 Compared With Baseline
Hb 1.5+ response is defined as a ≥1.5 g/dL increase in average Hb concentration from Week 12 through Week 24 compared with baseline. Hb 1.5+ response will be summarized using the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors. Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed.
Time frame: Double-Blind Period: Baseline up to Week 12 through Week 24
Double-Blind Period: Change From Baseline in Indirect Bilirubin at Week 24
Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed.
Time frame: Double-Blind Period: Baseline, Week 24
Double-Blind Period: Change From Baseline in Lactate Dehydrogenase (LDH) at Week 24
Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed.
Time frame: Double-Blind Period: Baseline, Week 24
Double-Blind Period: Change From Baseline in Haptoglobin at Week 24
Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed.
Time frame: Double-Blind Period: Baseline, Week 24
Double-Blind Period: Change From Baseline in Reticulocytes at Week 24
Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed.
Time frame: Double-Blind Period: Baseline, Week 24
Double-Blind Period: Change From Baseline in Erythropoietin at Week 24
Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed.
Time frame: Double-Blind Period: Baseline, Week 24
Double-Blind Period: Percentage of Participants Who Achieved Patient Global Impression of Severity (PGIS)- Fatigue Response at Weeks 12, 16, 20, and 24
PGIS-Fatigue measured participants' perception of their fatigue severity (7-day recall) on a 4-point scale ranging from '1=none' to '4=severe'. A participant was considered to have achieved the PGIS-Fatigue response at Weeks 12, 16, 20, or 24, if their baseline to postbaseline score met one of the following conditions: 'none' at baseline to 'none' postbaseline; 'mild' to 'mild' or 'none'; 'moderate' to 'mild' or 'none'; or 'severe' to 'moderate', 'mild', or 'none'.
Time frame: Double-Blind Period: At Weeks 12, 16, 20, and 24
Double-Blind Period: Percentage of Participants Who Achieved the Patient Global Impression of Change (PGIC)- Fatigue Response at Weeks 12, 16, 20, and 24
The PGIC-Fatigue assesses change over time compared with baseline on a 5-point scale ranging from 0 to 4 where 0 indicates Much better and 4 as Much worse. A participant was considered to have achieved the PGIC-Fatigue response at Weeks 12, 16, 20, or 24 if their baseline PGIS and corresponding PGIC met one of the following conditions: if the PGIS at baseline was 'none' or 'mild' and PGIC at the visit was 'no change', 'a little better', or 'much better'; or if the PGIS at baseline was 'moderate' or 'severe' and PGIC at the visit was 'a little better' or 'much better'.
Time frame: Double-Blind Period: At Weeks 12, 16, 20, and 24
Double-Blind Period: Change From Baseline in the 6-minute Walk Test (6MWT) Distance at Week 24
The 6MWT is a well-established performance outcome (PerfO) measure that is widely used to evaluate physical activity in terms of distance walked in patients with a variety of conditions. The test measures the distance an individual can walk on a hard, flat surface in 6 minutes.
Time frame: Double-Blind Period: Baseline, Week 24
Double-Blind Period: Change From Baseline in Serum Ferritin at Week 24
Iron metabolism was assessed based on serum ferritin levels.
Time frame: Double-Blind Period: Baseline, Week 24
Double-Blind Period: Change From Baseline in Transferrin Saturation (TSAT) at Week 24
Iron metabolism was assessed based on TSAT levels. Transferrin saturation is reported by dividing value of serum iron by total iron binding capacity.
Time frame: Double-Blind Period: Baseline, Week 24
Double-Blind Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs With Severity Greater Than or Equal to Grade 3
AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug. A serious adverse event (SAE) is any untoward medical occurrence that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are AEs with an initial onset date during the on-treatment period or worsening from baseline and includes both serious \& non-serious TEAEs. Severity of AEs was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; Version 4.03): grade 1: mild; grade 2: moderate; grade 3: severe or medically significant but not immediately life-threatening; grade 4: life threatening or disabling; grade 5: death related to AE.
Time frame: Double-Blind Period: From the time of signing informed consent to Week 24
Double-Blind Period: Plasma Concentration of Mitapivat
Time frame: Double-Blind Period: Pre-dose at Week 12; pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20
Double-Blind Period: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of Mitapivat
Area under the concentration-time curve from time zero to Tlast on dosing day, calculated using the linear-log trapezoidal rule.
Time frame: Double-Blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20
Double-Blind Period: Time of Last Quantifiable Concentration (Tlast) of Mitapivat
Time frame: Double-Blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20
Double-Blind Period: Maximum Observed Plasma Concentration (Cmax) of Mitapivat
Time frame: Double-Blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20
Double-Blind Period: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mitapivat
Time frame: Double-Blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20
Double-Blind Period: Last Quantifiable Plasma Concentration (Clast) of Mitapivat
Time frame: Double-Blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20
Double-Blind Period: Blood Concentration of Adenosine Triphosphate (ATP)
Time frame: Double-Blind Period: Pre-dose at Day 1; pre-dose at Week 12; pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20
Double-Blind Period: Blood Concentration of 2,3 - Diphosphoglycerate (2,3-DPG)
Time frame: Double-Blind Period: Pre-dose at Day 1; pre-dose at Week 12; pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20
Open-Label Extension Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs With Severity of Greater Than or Equal to Grade 3
AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug. A serious adverse event (SAE) is any untoward medical occurrence that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are AEs with an initial onset date during the on-treatment period or worsening from baseline and includes both serious \& non-serious TEAEs. Severity of abnormalities was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; Version 4.03): grade 1: mild; grade 2: moderate; grade 3: severe or medically significant but not immediately life-threatening; grade 4: life threatening or disabling; grade 5: death related to AE.
Time frame: Open-Label Extension Period: From week 24 up to end of study (approximately 5 years)

Results

Posted Jan 24, 2025

Participant flow

Participants took part in study at study sites in the United States of America, Brazil, Bulgaria, Canada, Denmark, France, Greece, Italy, Lebanon, Malaysia, Netherlands, Saudi Arabia, Spain, Taiwan, Thailand, Turkey, United Arab Emirates and the United Kingdom. Results are reported for 24-week DB period until primary completion date. Analysis of data for OLE period is still ongoing with anticipated completion in December 2028. Results for OLE period will be reported by December 2029.

Participant flow — Overall Study
Milestone	Mitapivat	Placebo
Started	130	64
Treated	129	63
Completed	122	62
Not completed	8	2
Withdrew: Randomized, never treated	1	1
Withdrew: Withdrawal by subject	3	1
Withdrew: Adverse event	2	0
Withdrew: Pregnancy	1	0
Withdrew: Other un-specified	1	0

Outcome measures

PrimaryDouble-Blind Period: Percentage of Participants Who Achieved Hemoglobin (Hb) Response From Week 12 Through Week 24 Compared With Baseline

Hb response is defined as ≥10 grams/ liter (g/L) (1.0 gram per deciliter) (g/dL) increase in average Hb concentration from Week 12 through Week 24 compared with baseline. Hb response was tested using the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors. Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed.

Time frame:: Double-Blind Period: Baseline up to Week 12 through Week 24
Reported as:: Number · Percentage of participants

Double-Blind Period: Percentage of Participants Who Achieved Hemoglobin (Hb) Response From Week 12 Through Week 24 Compared With Baseline
Percentage of participants	Mitapivat	Placebo
Double-Blind Period: Percentage of Participants Who Achieved Hemoglobin (Hb) Response From Week 12 Through Week 24 Compared With Baseline	42.3	1.6

Statistical analysis

Mitapivat vs Placebo · Cochran-Mantel-Haenszel · p = <0.0001 · Percentage difference: 40.9 · 95% CI 32.0 to 49.8

SecondaryDouble-Blind Period: Change From Baseline in Average Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue Subscale Score From Week 12 Through Week 24

The FACIT-Fatigue subscale includes a 13-item self-reported fatigue subscale, which assesses the severity and impact of fatigue (including the impact on daily activities and functioning).The FACIT-Fatigue subscale is scored on a 5-point Likert scale: 0 (not at all) to 4 (very much). The total FACIT-Fatigue subscale score ranges from 0 to 52, with a higher score indicating better health-related quality of life (HRQOL). Baseline is defined as the last assessment before randomization for subjects randomized and not dosed or the last assessment before start of study treatment for subjects randomized and dosed.

Time frame:: Double-Blind Period: Baseline, Week 12 through Week 24
Reported as:: Least squares mean · score on a scale

Double-Blind Period: Change From Baseline in Average Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue Subscale Score From Week 12 Through Week 24
score on a scale	Mitapivat	Placebo
Double-Blind Period: Change From Baseline in Average Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue Subscale Score From Week 12 Through Week 24	4.85 ± 0.732	1.46 ± 0.955

Statistical analysis

Mitapivat vs Placebo · ANCOVA · p = 0.0026 · Difference in lean square (ls) mean: 3.40 · 95% CI 1.21 to 5.59

SecondaryDouble-Blind Period: Change From Baseline in Average Hb Concentration From Week 12 Through Week 24

Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed.

Time frame:: Double-Blind Period: Baseline, Week 12 through Week 24
Reported as:: Least squares mean · Gram per Liter (g/L)

Double-Blind Period: Change From Baseline in Average Hb Concentration From Week 12 Through Week 24
Gram per Liter (g/L)	Mitapivat	Placebo
Double-Blind Period: Change From Baseline in Average Hb Concentration From Week 12 Through Week 24	8.57 ± 0.666	-1.06 ± 0.867

Statistical analysis

Mitapivat vs Placebo · ANCOVA · p = <0.0001 · Difference in ls mean: 9.63 · 95% CI 7.80 to 11.46

SecondaryDouble-Blind Period: Percentage of Participants Who Achieved Hb 1.5+ Response From Week 12 Through Week 24 Compared With Baseline

Hb 1.5+ response is defined as a ≥1.5 g/dL increase in average Hb concentration from Week 12 through Week 24 compared with baseline. Hb 1.5+ response will be summarized using the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors. Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed.

Time frame:: Double-Blind Period: Baseline up to Week 12 through Week 24
Reported as:: Number · Percentage of participants

Double-Blind Period: Percentage of Participants Who Achieved Hb 1.5+ Response From Week 12 Through Week 24 Compared With Baseline
Percentage of participants	Mitapivat	Placebo
Double-Blind Period: Percentage of Participants Who Achieved Hb 1.5+ Response From Week 12 Through Week 24 Compared With Baseline	24.6	0

SecondaryDouble-Blind Period: Change From Baseline in Indirect Bilirubin at Week 24

Time frame:: Double-Blind Period: Baseline, Week 24
Reported as:: Least squares mean · Micromole per Liter (umol/L)

Double-Blind Period: Change From Baseline in Indirect Bilirubin at Week 24
Micromole per Liter (umol/L)	Mitapivat	Placebo
Double-Blind Period: Change From Baseline in Indirect Bilirubin at Week 24	-10.65 ± 1.047	-0.03 ± 1.403

SecondaryDouble-Blind Period: Change From Baseline in Lactate Dehydrogenase (LDH) at Week 24

Time frame:: Double-Blind Period: Baseline, Week 24
Reported as:: Least squares mean · Units per Liter (U/L)

Double-Blind Period: Change From Baseline in Lactate Dehydrogenase (LDH) at Week 24
Units per Liter (U/L)	Mitapivat	Placebo
Double-Blind Period: Change From Baseline in Lactate Dehydrogenase (LDH) at Week 24	-30.07 ± 7.131	-5.79 ± 9.440

SecondaryDouble-Blind Period: Change From Baseline in Haptoglobin at Week 24

Time frame:: Double-Blind Period: Baseline, Week 24
Reported as:: Least squares mean · Gram per Liter (g/L)

Double-Blind Period: Change From Baseline in Haptoglobin at Week 24
Gram per Liter (g/L)	Mitapivat	Placebo
Double-Blind Period: Change From Baseline in Haptoglobin at Week 24	-0.002 ± 0.0145	0.017 ± 0.0199

SecondaryDouble-Blind Period: Change From Baseline in Reticulocytes at Week 24

Time frame:: Double-Blind Period: Baseline, Week 24
Reported as:: Least squares mean · 10^9 cells per liter (10^9 cells/L)

Double-Blind Period: Change From Baseline in Reticulocytes at Week 24
10^9 cells per liter (10^9 cells/L)	Mitapivat	Placebo
Double-Blind Period: Change From Baseline in Reticulocytes at Week 24	-32.11 ± 10.600	-14.74 ± 14.932

SecondaryDouble-Blind Period: Change From Baseline in Erythropoietin at Week 24

Time frame:: Double-Blind Period: Baseline, Week 24
Reported as:: Least squares mean · International units per Liter (IU/L)

Double-Blind Period: Change From Baseline in Erythropoietin at Week 24
International units per Liter (IU/L)	Mitapivat	Placebo
Double-Blind Period: Change From Baseline in Erythropoietin at Week 24	19.21 ± 37.773	115.71 ± 49.413

SecondaryDouble-Blind Period: Percentage of Participants Who Achieved Patient Global Impression of Severity (PGIS)- Fatigue Response at Weeks 12, 16, 20, and 24

PGIS-Fatigue measured participants' perception of their fatigue severity (7-day recall) on a 4-point scale ranging from '1=none' to '4=severe'. A participant was considered to have achieved the PGIS-Fatigue response at Weeks 12, 16, 20, or 24, if their baseline to postbaseline score met one of the following conditions: 'none' at baseline to 'none' postbaseline; 'mild' to 'mild' or 'none'; 'moderate' to 'mild' or 'none'; or 'severe' to 'moderate', 'mild', or 'none'.

Time frame:: Double-Blind Period: At Weeks 12, 16, 20, and 24
Reported as:: Number · percentage of participants

Double-Blind Period: Percentage of Participants Who Achieved Patient Global Impression of Severity (PGIS)- Fatigue Response at Weeks 12, 16, 20, and 24
percentage of participants	Mitapivat	Placebo
At Week 12	65.4	46.9
At Week 16	63.1	42.2
At Week 20	61.5	48.4
At Week 24	62.3	46.9

SecondaryDouble-Blind Period: Percentage of Participants Who Achieved the Patient Global Impression of Change (PGIC)- Fatigue Response at Weeks 12, 16, 20, and 24

The PGIC-Fatigue assesses change over time compared with baseline on a 5-point scale ranging from 0 to 4 where 0 indicates Much better and 4 as Much worse. A participant was considered to have achieved the PGIC-Fatigue response at Weeks 12, 16, 20, or 24 if their baseline PGIS and corresponding PGIC met one of the following conditions: if the PGIS at baseline was 'none' or 'mild' and PGIC at the visit was 'no change', 'a little better', or 'much better'; or if the PGIS at baseline was 'moderate' or 'severe' and PGIC at the visit was 'a little better' or 'much better'.

Time frame:: Double-Blind Period: At Weeks 12, 16, 20, and 24
Reported as:: Number · percentage of participants

Double-Blind Period: Percentage of Participants Who Achieved the Patient Global Impression of Change (PGIC)- Fatigue Response at Weeks 12, 16, 20, and 24
percentage of participants	Mitapivat	Placebo
At Week 12	71.5	53.1
At Week 16	71.5	50.0
At Week 20	66.2	56.3
At Week 24	66.2	53.1

SecondaryDouble-Blind Period: Change From Baseline in the 6-minute Walk Test (6MWT) Distance at Week 24

The 6MWT is a well-established performance outcome (PerfO) measure that is widely used to evaluate physical activity in terms of distance walked in patients with a variety of conditions. The test measures the distance an individual can walk on a hard, flat surface in 6 minutes.

Time frame:: Double-Blind Period: Baseline, Week 24
Reported as:: Least squares mean · Meters

Double-Blind Period: Change From Baseline in the 6-minute Walk Test (6MWT) Distance at Week 24
Meters	Mitapivat	Placebo
Double-Blind Period: Change From Baseline in the 6-minute Walk Test (6MWT) Distance at Week 24	30.48 ± 5.651	7.11 ± 7.346

SecondaryDouble-Blind Period: Change From Baseline in Serum Ferritin at Week 24

Iron metabolism was assessed based on serum ferritin levels.

Time frame:: Double-Blind Period: Baseline, Week 24
Reported as:: Least squares mean · Microgram/Liter (mcg/L)

Double-Blind Period: Change From Baseline in Serum Ferritin at Week 24
Microgram/Liter (mcg/L)	Mitapivat	Placebo
Double-Blind Period: Change From Baseline in Serum Ferritin at Week 24	-34.75 ± 32.710	-32.48 ± 43.090

SecondaryDouble-Blind Period: Change From Baseline in Transferrin Saturation (TSAT) at Week 24

Iron metabolism was assessed based on TSAT levels. Transferrin saturation is reported by dividing value of serum iron by total iron binding capacity.

Time frame:: Double-Blind Period: Baseline, Week 24
Reported as:: Least squares mean · Ratio

Double-Blind Period: Change From Baseline in Transferrin Saturation (TSAT) at Week 24
Ratio	Mitapivat	Placebo
Double-Blind Period: Change From Baseline in Transferrin Saturation (TSAT) at Week 24	-0.029 ± 0.0212	-0.047 ± 0.0262

SecondaryDouble-Blind Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs With Severity Greater Than or Equal to Grade 3

AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug. A serious adverse event (SAE) is any untoward medical occurrence that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are AEs with an initial onset date during the on-treatment period or worsening from baseline and includes both serious \& non-serious TEAEs. Severity of AEs was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; Version 4.03): grade 1: mild; grade 2: moderate; grade 3: severe or medically significant but not immediately life-threatening; grade 4: life threatening or disabling; grade 5: death related to AE.

Time frame:: Double-Blind Period: From the time of signing informed consent to Week 24
Reported as:: Count of participants · Participants

Double-Blind Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs With Severity Greater Than or Equal to Grade 3
Participants	Mitapivat	Placebo
Participants with TEAEs	107	50
Participants with Serious TEAEs	8	0
Participants with TEAEs related to study drug	56	13
Participants with any TEAE of Grade ≥ 3	18	2

SecondaryDouble-Blind Period: Plasma Concentration of Mitapivat

Time frame:: Double-Blind Period: Pre-dose at Week 12; pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20
Reported as:: Mean · nanograms per milliliter (ng/mL)

Double-Blind Period: Plasma Concentration of Mitapivat
nanograms per milliliter (ng/mL)	Mitapivat
Pre-dose at Week 12	59.23 ± 51.081
Pre-dose at Week 20	84.70 ± 138.852
30 Minutes Post-dose at Week 20	1209.00 ± 931.211
1 Hour Post-dose at Week 20	1386.35 ± 712.996
3 Hour Post-dose at Week 20	740.26 ± 357.660
5 Hour Post-dose at Week 20	359.42 ± 269.758
7 Hour Post-dose at Week 20	206.82 ± 185.657

SecondaryDouble-Blind Period: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of Mitapivat

Area under the concentration-time curve from time zero to Tlast on dosing day, calculated using the linear-log trapezoidal rule.

Time frame:: Double-Blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20
Reported as:: Geometric mean · Hours*nanogram per milliliter (h*ng/mL)

Double-Blind Period: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of Mitapivat
Hoursnanogram per milliliter (hng/mL)	Mitapivat
Double-Blind Period: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of Mitapivat	4262.57 ± 31.4

SecondaryDouble-Blind Period: Time of Last Quantifiable Concentration (Tlast) of Mitapivat

Time frame:: Double-Blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20
Reported as:: Median · hours

Double-Blind Period: Time of Last Quantifiable Concentration (Tlast) of Mitapivat
hours	Mitapivat
Double-Blind Period: Time of Last Quantifiable Concentration (Tlast) of Mitapivat	6.825 (6.50 to 7.42)

SecondaryDouble-Blind Period: Maximum Observed Plasma Concentration (Cmax) of Mitapivat

Time frame:: Double-Blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20
Reported as:: Geometric mean · ng/mL

Double-Blind Period: Maximum Observed Plasma Concentration (Cmax) of Mitapivat
ng/mL	Mitapivat
Double-Blind Period: Maximum Observed Plasma Concentration (Cmax) of Mitapivat	1565.69 ± 42.4

SecondaryDouble-Blind Period: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mitapivat

Time frame:: Double-Blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20
Reported as:: Median · Hours

Double-Blind Period: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mitapivat
Hours	Mitapivat
Double-Blind Period: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mitapivat	1.000 (0.20 to 5.00)

SecondaryDouble-Blind Period: Last Quantifiable Plasma Concentration (Clast) of Mitapivat

Time frame:: Double-Blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20
Reported as:: Geometric mean · ng/mL

Double-Blind Period: Last Quantifiable Plasma Concentration (Clast) of Mitapivat
ng/mL	Mitapivat
Double-Blind Period: Last Quantifiable Plasma Concentration (Clast) of Mitapivat	166.93 ± 80.1

SecondaryDouble-Blind Period: Blood Concentration of Adenosine Triphosphate (ATP)

Time frame:: Double-Blind Period: Pre-dose at Day 1; pre-dose at Week 12; pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20
Reported as:: Mean · microgram/milliliter (mcg/mL)

Double-Blind Period: Blood Concentration of Adenosine Triphosphate (ATP)
microgram/milliliter (mcg/mL)	Mitapivat	Placebo
At Pre-dose at Day 1	180.87 ± 29.577	184.91 ± 31.299
Pre-dose at Week 12	242.07 ± 45.782	176.81 ± 33.657
Pre-dose at Week 20	235.79 ± 46.099	168.10 ± 29.962
30 Minutes Post-dose at Week 20	417.87 ± 102.853	457.78 ± 89.932
1 Hour Post-dose at Week 20	417.83 ± 105.752	457.71 ± 104.431
3 Hour Post-dose at Week 20	409.73 ± 96.379	454.39 ± 107.966
5 Hour Post-dose at Week 20	412.72 ± 94.150	464.24 ± 97.007
7 Hour Post-dose at Week 20	404.43 ± 97.586	471.10 ± 113.165

SecondaryDouble-Blind Period: Blood Concentration of 2,3 - Diphosphoglycerate (2,3-DPG)

Time frame:: Double-Blind Period: Pre-dose at Day 1; pre-dose at Week 12; pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20
Reported as:: Mean · mcg/mL

Double-Blind Period: Blood Concentration of 2,3 - Diphosphoglycerate (2,3-DPG)
mcg/mL	Mitapivat	Placebo
Pre-dose at Day 1	526.40 ± 125.196	506.14 ± 108.033
Pre-dose at Week 12	434.90 ± 97.901	497.68 ± 112.055
Pre-dose at Week 20	426.30 ± 107.173	468.22 ± 99.783
30 Minutes Post-dose at Week 20	417.87 ± 102.853	457.78 ± 89.932
1 Hour Post-dose at Week 20	417.83 ± 105.752	457.71 ± 104.431
3 Hour Post-dose at Week 20	409.73 ± 96.379	454.39 ± 107.966
5 Hour Post-dose at Week 20	412.72 ± 94.150	464.24 ± 97.007
7 Hour Post-dose at Week 20	404.43 ± 97.586	471.10 ± 113.165

SecondaryOpen-Label Extension Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs With Severity of Greater Than or Equal to Grade 3

AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug. A serious adverse event (SAE) is any untoward medical occurrence that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are AEs with an initial onset date during the on-treatment period or worsening from baseline and includes both serious \& non-serious TEAEs. Severity of abnormalities was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; Version 4.03): grade 1: mild; grade 2: moderate; grade 3: severe or medically significant but not immediately life-threatening; grade 4: life threatening or disabling; grade 5: death related to AE.

Time frame:: Open-Label Extension Period: From week 24 up to end of study (approximately 5 years)

Results for this outcome have not been posted.

Adverse events

Collected over Double-blind period: From the time of signing informed consent to Week 24. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Mitapivat	0/130 (0%)	8/129 (6.2%)	80/129 (62%)
Placebo	0/64 (0%)	0/63 (0%)	33/63 (52.4%)

Most frequent serious events

Most frequent serious events
Event	Mitapivat	Placebo
Lower respiratory tract infectionInfections and infestations	1/129	0/63
PneumoniaInfections and infestations	1/129	0/63
Upper respiratory tract infectionInfections and infestations	1/129	0/63
Craniofacial fractureInjury, poisoning and procedural complications	1/129	0/63
Ulna fractureInjury, poisoning and procedural complications	1/129	0/63
AnaemiaBlood and lymphatic system disorders	1/129	0/63
Angina pectorisCardiac disorders	1/129	0/63
Abdominal painGastrointestinal disorders	1/129	0/63
Superficial vein thrombosisVascular disorders	1/129	0/63

Most frequent other events

Showing 10 of 15

Most frequent other events
Event	Mitapivat	Placebo
HeadacheNervous system disorders	29/129	6/63
Initial insomniaPsychiatric disorders	18/129	3/63
NauseaGastrointestinal disorders	15/129	5/63
Upper respiratory tract infectionInfections and infestations	13/129	4/63
InfluenzaInfections and infestations	5/129	6/63
DiarrhoeaGastrointestinal disorders	11/129	6/63
PyrexiaGeneral disorders	4/129	6/63
FatigueGeneral disorders	12/129	4/63
COVID-19Infections and infestations	8/129	5/63
Back painMusculoskeletal and connective tissue disorders	3/129	5/63

Baseline characteristics

Full Analysis Set (FAS) included all participants who were randomized.

Age, Continuous
Age, Continuous(years)	Mitapivat	Placebo	Total
Mean	42.4 ± 13.03	38.9 ± 12.99	41.2 ± 13.09

Sex: Female, Male
Sex: Female, Male(Participants)	Mitapivat	Placebo	Total
Female	84	39	123
Male	46	25	71

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Mitapivat	Placebo	Total
Hispanic or Latino	11	6	17
Not Hispanic or Latino	118	58	176
Unknown or Not Reported	1	0	1

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Mitapivat	Placebo	Total
White	73	36	109
Asian	52	24	76
Black or African American	1	1	2
American Indian or Alaska Native	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Multiracial	1	0	1
Unknown	2	2	4
Not reported	1	1	2

Study locations

68 sites

San Diego Hospital, UC San Diego Health
La Jolla, California 92093, United States
Stanford Medicine
Palo Alto, California 94304-1601, United States
Massachusetts General Hospital
Boston, Massachusetts 02114-2696, United States
Weill Cornell Medical Center
New York, New York 10065-4870, United States
Duke University Medical Center
Durham, North Carolina 27710-3038, United States
Penn Medicine - University of Pennsylvania Health System
Philadelphia, Pennsylvania 19104, United States
Universidade de Caxias do Sul
Caxias do Sul, 95070-560, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, 14051-260, Brazil
HEMORIO Instituto Nacional de Hematologia
Rio de Janeiro, 20211-030, Brazil
Praxis Pesquisa Medica
Santo André, 09090-790, Brazil
GSH Banco de Sangue de São Paulo
São Paulo, 04006-002, Brazil
Instituto do Cancer do Estado de São Paulo, Hospital das Clínicas da Faculdade de Medicina da Universidad de São Paulo
São Paulo, 05403-000, Brazil
MHAT "Dr. Nikola Vasiliev" AD
Kyustendil, 2500, Bulgaria
SHATHD Sofia
Sofia, 1756, Bulgaria
Toronto General Hospital, University Health Network
Toronto, M5G 2C4, Canada
Rigshospitalet
Copenhagen, 2100, Denmark
CHU Hôpital Henri Mondor
Créteil, 94010, France
Hopital Edouard Herriot, CHU de Lyon
Lyon, 69003, France
Laiko General Hospital
Athens, 115 26, Greece
Children's Hospital Agia Sophia, National and Kapodistrian University of Athens Medical School
Athens, 115 27, Greece
University General Hospital of Patras
Rio, 26504, Greece
Ippokrateio General Hospital
Thessaloniki, 546 42, Greece
Ospedale "A. Perrino" - Brindisi
Brindisi, 72100, Italy
Ospedale Pediatrico Microcitemico
Cagliari, 09121, Italy
Ospedale Sant'Anna
Ferrara, 44124, Italy
Ente Ospedaliero Ospedali Galliera
Genova, 16128, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
A.O.U Di Modena
Modena, 41124, Italy
A.O.R.N. "A. Cardarelli"
Naples, 80131, Italy
AOU L. Vanvitelli Universita degli Studi della Campania Luigi Vanvitelli
Naples, 80138, Italy
A.O.U. San Luigi Gonzaga
Orbassano, 10043, Italy
Chronic Care Center
Beirut, 9999, Lebanon
Hospital Sultanah Bahiyah
Alor Star, 05460, Malaysia
Hospital Ampang
Ampang, 68000, Malaysia
Hospital Sultanah Aminah Johor Bahru
Johor Bahru, 80100, Malaysia
Hospital Queen Elizabeth, Kota Kinabalu
Kota Kinabalu, 88586, Malaysia
Hospital Tunku Azizah
Kuala Lumpur, 50300, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, 25100, Malaysia
Hospital Umum Sarawak
Kuching, 93586, Malaysia
Hospital Pulau Pinang
Pulau Pinang, 10990, Malaysia
Erasmus MC
Rotterdam, 3015 GD, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX, Netherlands
King Abdulaziz Hospital - Al Ahsa
Al Mubarraz, 36428, Saudi Arabia
King Abdullah International Medical Research Center
Riyadh, 14611, Saudi Arabia
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Virgen Arrixaca
Murcia, 30120, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
China Medical University, Taiwan
Taichung, 40447, Taiwan
Phramongkutklao Hospital
Bangkok, 10400, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand
Faculty of Medicine Siriraj Hospital
Bangkok, 10700, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200, Thailand
Srinagarind Hospital, Khon Kaen University
Khon Kaen, 40002, Thailand
Naresuan University Hospital
Mueang Phitsanulok, 65000, Thailand
King Chulalongkorn Memorial Hospital
Pathum Wan, 10330, Thailand
Acibadem Adana Hospital
Adana, 01130, Turkey (Türkiye)
Akdeniz University Faculty of Medicine
Antalya, 07059, Turkey (Türkiye)
Çukurova University
Balcalı, 01330, Turkey (Türkiye)
Ege University Faculty of Medicine
Bornova, 35040, Turkey (Türkiye)
Istanbul University Faculty of Medicine
Fatih, 34093, Turkey (Türkiye)
Hacettepe University
Mersin, 06230, Turkey (Türkiye)
Burjeel Medical City
Abu Dhabi, United Arab Emirates
Thalassemia Centre Dubai
Dubai, 4545, United Arab Emirates
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
Cambridge, CAM CB2 0QQ, United Kingdom
Manchester Royal Infirmary, Manchester University NHS Foundation Trust
Manchester, LAN M13 9WL, United Kingdom
University College London
London, NW1 2PG, United Kingdom
Imperial College Healthcare NHS Trust - Hammersmith Hospital
London, W12 OHS, United Kingdom

References and documents

Publications

Taher AT, Al-Samkari H, Aydinok Y, Besser M, Boscoe AN, Dahlin JL, De Luna G, Estepp JH, Gheuens S, Gilroy KS, Glenthoj A, Sim Goh A, Iyer V, Kattamis A, Loggetto SR, Morris S, Musallam KM, Osman K, Ricchi P, Salido-Fierrez E, Sheth S, Tai F, Tevich H, Uhlig K, Urbstonaitis R, Viprakasit V, Cappellini MD, Kuo KHM; ENERGIZE investigators. Mitapivat in adults with non-transfusion-dependent alpha-thalassaemia or beta-thalassaemia (ENERGIZE): a phase 3, international, randomised, double-blind, placebo-controlled trial. Lancet. 2025 Jul 5;406(10498):33-42. doi: 10.1016/S0140-6736(25)00635-X. Epub 2025 Jun 19. PubMed 40544857 ↗

Study documents

Study protocol · Aug 5, 2024
Statistical analysis plan · Nov 14, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

1 registry update since Sep 25, 2026

Minor edits

Nothing that changes what the study is or who can join. Edited: verification date

1 update, last Sep 28, 2026

Show all 1 update

Sep 28, 2026
Minor edits only
+ 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04770753
Lead sponsor: Agios Pharmaceuticals, Inc.
Responsible party: Sponsor
First posted: Feb 25, 2021
Start date: Dec 20, 2021
Primary completion: Nov 13, 2023
Completion: Dec 2028 (estimated)
Results posted: Jan 24, 2025
Last update: Sep 28, 2026

Study contacts

Medical Affairs

study chair · Agios Pharmaceuticals, Inc.

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Agios Pharmaceuticals, Inc.

Start the discussion

A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)

Study summary

Conditions studied

In context

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Study documents

Individual participant data

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies from this sponsor

Inclusion criteria

Exclusion criteria